17670 results
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Orphan designation: Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase 3) for: Treatment of chronic myeloid leukaemia
Date of designation: 21/12/2004, Withdrawn, Last updated: 19/11/2009Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … -
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Orphan designation: Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase 3) for: Treatment of acute myeloid leukaemia
Date of designation: 21/12/2004, Withdrawn, Last updated: 19/11/2009Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … -
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Orphan designation: Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase 3) for: Treatment of myelodysplastic syndromes
Date of designation: 21/12/2004, Withdrawn, Last updated: 06/01/2006Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … -
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Human medicine European public assessment report (EPAR): Starlix
nateglinide, Diabetes Mellitus, Type 2
Date of authorisation: 03/04/2001, Revision: 15, Withdrawn, Last updated: 28/06/2022Diseases Metabolic Diseases Glucose Metabolism Disorders Diabetes … nateglinide … authorisation for Starlix (nateglinide) in the European Union (EU … -
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Orphan designation: N-acetylsarcosyl-glycyl-L-valyl-D-alloisoleucyl-L-threonyl-L-norvalyl-L-isoleucyl-L-arginyl-L-prolyl-N-ethylamide for: Treatment of soft tissue sarcoma
Date of designation: 12/12/2003, Withdrawn, Last updated: 15/10/2009N-acetylsarcosyl-glycyl-L-valyl-D-alloisoleucyl-L-threonyl-L-norvalyl-L-isoleucyl-L-arginyl-L-prolyl-N-ethylamide … N-acetylsarcosyl-glycyl-L-valyl-D-allo-isoleucyl-L-threonyl-L-norvalyl-L-isoleucyl-L-arginyl-L-propyl-N-ethylamide for the treatment of soft … orphan designation of N-acetylsarcosyl-glycyl-L-valyl-D-allo-isoleucyl-L-threonyl-L-norvalyl-L-isoleucyl-L- arginyl-L-propyl-N-ethylamide … -
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Orphan designation: C-type natriuretic peptide conjugated to multi-arm polyethylene glycol carrier through a cleavable linker for: Treatment of achondroplasia
Date of designation: 27/07/2020, Positive, Last updated: 19/11/2020C-type natriuretic peptide conjugated to multi-arm … to multi-arm polyethylene glycol carrier through a cleavable … C-type natriuretic peptide conjugated to multi-arm … -
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Opinion/decision on a Paediatric investigation plan (PIP): N-Acetyl-L-Cysteine (corresponds to L-Cysteine), L-Alanine, L-Alanyl-L-Glutamine (corresponds to L-Alanine and L-Glutamine), L-Arginine, Glycine, Glycyl-L-Tyrosine (corresponds to Glycine and L-Tyrosine), L-Histidine, L-Isoleucine, L-Leucine, L-Lysine acetate (corresponds to L-Lysine), LMethionine, L-Phenylalanine, L-Proline, L-Serine, Taurine, L-Threonine, L-Tryptophan, L-Valine
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Nutrition
PIP number: EMEA-000042-PIP01-07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 07/09/2009, Last updated: 22/10/2009, Compliance check: XKey facts N-Acetyl-L-Cysteine (corresponds to L-Cysteine … L-Cysteine), L-Alanine, L-Alanyl-L-Glutamine (corresponds to L-Alanine … corresponds to L-Alanine and L-Glutamine), L-Arginine … -
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Summary of opinion: Bovilis Nasalgen-C
bovine coronavirus, strain CA25, live, opinion date: 15/02/2023, Positive, Last updated: 17/02/2023Bovilis Nasalgen-C: Pending EC decision … Bovilis Nasalgen-C … authorisation) Bovilis Nasalgen-C Common name: Bovine coronavirus vaccine … -
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Human medicine European public assessment report (EPAR): Natalizumab Elan Pharma
natalizumab, Crohn Disease
Date of refusal: 11/01/2008, Refused, Last updated: 25/01/2008Natalizumab Elan Pharma Crohn Disease … Refused natalizumab Overview On 19 July 2007 … for the medicinal product Natalizumab Elan Pharma concentrate for … -
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Orphan designation: Poly(oxy-1,2-ethanediyl),.alpha.-hydro-.omega.-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-.alpha.-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide cyclic (2.fwdarw.12)-(disulfide); where two identical synthetic peptide domains are covalently linked at the ends of the polyethylene glycol chain for: Treatment of paroxysmal nocturnal haemoglobinuria
Date of designation: 22/05/2017, Positive, Last updated: 16/12/2021hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L glutaminyl-L-.alpha.-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide … Poly(oxy-1,2-ethanediyl),.alpha.-hydro-.omega.-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L glutaminyl-L-.alpha.-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide … -
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Human medicine European public assessment report (EPAR): Tyruko (updated)
natalizumab, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 22/09/2023,
, 
, Revision: 1, Authorised, Last updated: 20/11/2023
natalizumab … EMEA/H/C/005752 Tyruko (natalizumab) An overview of Tyruko and … contains the active substance natalizumab. How is Tyruko used? The … -
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Human medicine European public assessment report (EPAR): Tysabri (updated)
natalizumab, Multiple Sclerosis
Date of authorisation: 27/06/2006, Revision: 41, Authorised, Last updated: 20/11/2023natalizumab … on the review of Tysabri (natalizumab) Outcome of a procedure … completed a review of Tysabri (natalizumab) at the request of the European … -
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Orphan designation: Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-alpha-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide cyclic (2.fwdarw.12)-(disulfide); where two identical synthetic peptide domains are covalently linked at the ends of the polyethylene glycol chain (pegcetacoplan) for: Treatment of C3 glomerulopathy
Date of designation: 21/08/2019, Positive, Last updated: 03/02/2021alpha-hydro-omega-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L glutaminyl-L-alpha-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate), histidine, tryptophan, aspartic acid, n-acetyl-histidine (monohydrate), glycine, alpha-ketoglutaric acid, arginine, potassium chloride, magnesium chloride (hexahydrate), calcium chloride (dihydrate), sodium chloride, alanine, 3,4-dimethoxy-N-methylbenzohydroxamic acid (Custodiol-N)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002735-PIP03-20-M01, Pharmaceutical form(s): Solution for organ preservation
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: Xtryptophan aspartic acid n-acetyl-histidine (monohydrate glycine alpha-ketoglutaric acid arginine … tryptophan / aspartic acid / n-acetyl-histidine (monohydrate glycine / alfa- ketoglutaric acid … tryptophan / aspartic acid / n-acetyl-histidine (monohydrate glycine / alfa- ketoglutaric acid … -
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Human medicine European public assessment report (EPAR): Moventig (updated)
naloxegol oxalate, Constipation; Opioid-Related Disorders
Date of authorisation: 07/12/2014, Revision: 15, Authorised, Last updated: 13/11/2023Disorders Substance-Related Disorders Narcotic-Related Disorders Mental Disorders Constipation Opioid-Related … Authorised naloxegol Overview This is a summary … medicine. active substance naloxegol. How is Moventig used? Moventig … -
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Human medicine European public assessment report (EPAR): Suboxone (updated)
buprenorphine, naloxone, Opioid-Related Disorders
Date of authorisation: 26/09/2006, Revision: 22, Authorised, Last updated: 20/11/2023Disorders Substance-Related Disorders Narcotic-Related Disorders Mental Disorders Opioid-Related … treat dependence on opioid (narcotic) drugs such as heroin or … substances , buprenorphine and naloxone. How is Suboxone used? Suboxone … -
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Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate), histidine, tryptophan, aspartic acid, n-acetyl-histidine (monohydrate), glycine, alpha-ketoglutaric acid, arginine, potassium chloride, magnesium chloride (hexahydrate), calcium chloride (dihydrate), sodium chloride, alanine, 3,4-dimethoxy-N-methylbenzohydroxamic
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002735-PIP01-19, Route(s) of administration: Intracoronary use, Pharmaceutical form(s): Concentrate and solvent for solution for infusion
Decision date: 09/06/2021, Last updated: 26/04/2022, Compliance check: Xtryptophan aspartic acid n-acetyl-histidine (monohydrate glycine alpha-ketoglutaric acid arginine … tryptophan / aspartic acid / n-acetyl-histidine (monohydrate glycine / alpha- ketoglutaric acid … tryptophan / aspartic acid / n-acetyl-histidine (monohydrate glycine / alpha- ketoglutaric acid … -
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Referral: Tysabri
natalizumab, associated names: Tysabri, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 25/04/2016, Last updated: 12/05/2016sclerosis medicine Tysabri (natalizumab), and confirmed initial … Tysabri Tysabri natalizumab natalizumab natalizumab … -
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Human medicine European public assessment report (EPAR): Nyxoid
Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 09/11/2017, Revision: 8, Authorised, Last updated: 24/02/2023Disorders Substance-Related Disorders Narcotic-Related Disorders Mental Disorders Opioid-Related … naloxone … for the public Nyxoid naloxone This is a summary of the … -
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Human medicine European public assessment report (EPAR): Trazec
nateglinide, Diabetes Mellitus, Type 2
Date of authorisation: 03/04/2001, Revision: 5, Withdrawn, Last updated: 24/08/2009nateglinide … Trazec, INN-nateglinide European Medicines … Union for Trazec nateglinide On 3 April 2001, the … -
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Human medicine European public assessment report (EPAR): Selincro
Nalmefene hydrochloride dihydrate, Alcohol-Related Disorders
Date of authorisation: 24/02/2013, Revision: 13, Authorised, Last updated: 17/05/2022Authorised nalmefene Overview This is a summary … contains the active substance nalmefene. It is available as tablets … active substance in Selincro, nalmefene, attaches to certain opioid … -
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Veterinary medicine European public assessment report (EPAR): Gonazon
azagly-nafarelin, Dogs; Salmonidae (Salmonid fish)
Date of authorisation: 20/07/2003, Revision: 7, Withdrawn, Last updated: 15/08/2012Withdrawn azagly-nafarelin Overview The marketing authorisation … statement on Gonazon (azagly-nafarelin) Withdrawal of the marketing … statement on Gonazon (azagly-nafarelin) Withdrawal of the marketing … -
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Summary of opinion: Naveruclif (new)
paclitaxel, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023Naveruclif: Pending EC decision … Naveruclif … initial authorisation) Naveruclif paclitaxel On 9 November … -
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Human medicine European public assessment report (EPAR): Mysimba
bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015,, Revision: 25, Authorised, Last updated: 21/07/2023
Authorised naltrexonebupropion Overview This is a summary … medicine. active substances naltrexone and bupropion, which are … tablets containing 7.2 mg naltrexone and 78 mg bupropion and can … -
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Herbal medicinal product: Echinaceae angustifoliae radix
Echinacea angustifolia DC., Narrow-leaved coneflower root, F: Assessment finalised, Last updated: 23/04/2019Latin name Echinaceae angustifoliae … angustifoliae radix English common name Narrow-leaved coneflower root Botanical name Echinacea angustifolia DC … radix Echinacea angustifolia DC. Narrow-leaved coneflower root …